|- candidate number||28371|
|- NTR Number||NTR7021|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-dec-2017|
|- Secondary IDs||NL61965.031.17 M17GINV|
|- Public Title||De status van het micromilieu van de (schildwacht)klieren en tumor bij patiŽnten met HPV-positieve en HPV-negatieve kanker van de schaamlippen.|
|- Scientific Title||The state of the (sentinel) lymph node and tumour microenvironment in patients with HPV-positive and HPV-negative vulvar cancer.|
|- ACRONYM||GINA (vulva)|
|- hypothesis||This is an exploratory study to further delineate the microenvironment of the PT and (S)LNs in HPV-positive and HPV-negative vulvar cancer. |
|- Healt Condition(s) or Problem(s) studied||Human Papilloma Virus (HPV), Vulvar cancer, Lymph nodes, Sentinel lymph node|
|- Inclusion criteria||- Age ≥ 18 years at start of the study;|
- Primary carcinoma of the vulva with an indication for sentinel node procedure or inguinofemoral
- Operation at the NKI-AVL or AMC/VUmc;
- Signed informed consent.
|- Exclusion criteria||- PatiŽnts who had previous therapy for macro invasive vulvar cancer (including sentinel node procedure) will not
participate in the sentinel node part of the study.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-feb-2018|
|- planned closingdate||1-feb-2023|
|- Target number of participants||100|
|- Interventions||Patients who will undergo a lymphadenectomy will be asked to participate in detecting the SLNs prior to the lymph node dissection by injecting patent blue in the tumour margins before the (local) excision of the tumour (if applicable) on the operation room. In case only a lymph node dissection/debulking and no local excision of the tumour will be performed, the patient will be asked permission to perform a small tumour biopsy on the operation room. |
Different subsets of the antigen presenting cells and other immune cells in the microenvironment will be measured by the use of multi-color flow cytometry and multi-parameter immunohistochemistry.
|- Primary outcome||To analyse the microenvironment of (S)LNs and PT (i.e. various T-cell populations, antigen presenting cells and myeloid suppressor cells) and other immune factors produced by the tumour cells in patients with vulvar cancer. |
|- Secondary outcome||- to assess the differences of the microenvironment in HPV-positive and HPV-negative (S)LNs|
- to assess the difference of the microenvironment of tumour-negative and metastatic (S)LNs.
- to assess the difference of the microenvironment of SLNs and non-SLNs.
- to analyse the difference in the (S)LNs compared to the PT.
|- Timepoints||All interventions will be performed on the same day|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||drs. Jossie Rotman|
|- CONTACT for SCIENTIFIC QUERIES||drs. Jossie Rotman|
|- Sponsor/Initiator ||NKI-AVL|
(Source(s) of Monetary or Material Support)
|- Brief summary||This is an exploratory study to further delineate the microenvironment of the primary tumour and (sentinel) lymph nodes (SLN) in HPV-positive and HPV-negative vulvar cancer. All patients diagnosed with vulvar carcinoma who will undergo a sentinel node procedure or a lymphadenectomy/lymph node debulking will be asked to participate in the study. Patients who will undergo a lymphadenectomy will be asked to participate in detecting the SLNs prior to the lymph node dissection by injecting patent blue in the tumour margins before the (local) excision of the tumour (if applicable) on the operation room. In case only a lymph node dissection/debulking and no local excision of the tumour will be performed, the patient will be asked permission to obtaina small tumour biopsy on the operation room.|
|- Main changes (audit trail)|
|- RECORD||21-dec-2017 - 23-feb-2018|